HD-Idarubicin/Etoposide Intensified Conditioning Regimen Allo-HSCT for Adult ALL

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying condition with less-used drugs could overcome resistance,reduce tumor burden, and most importantly, spare enough time for slow-growing GVL effect following immune reconstitution to finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011 (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL, resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2 conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16 conditioning regimen was associated with high transplantation-related mortality (TRM), which might be attributed to excessive suppression on both bone marrow and immune. TT-ALL-HIE-2013, substituting FA with idarubicin, is aimed at maintaining anti-tumor effect with less cross-resistance and immune suppression and reducing TRM.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Treatments: Cyclophosphamide; Etoposide; Etoposide phosphate; Idarubicin

Criteria

Inclusion Criteria:

1. Age: 16 years to 65 years;

2. Diagnosis of acute lymphoblastic leukemia;

3. Patient receives allo-HSCT;

4. The informed consent form has been signed;

Exclusion Criteria:

1. Patient with severe cardiac dysfunction with less than 50% EF;

2. Patient with severe lung dysfunction;

3. Patient with more than 3 times ULN of serum ALT or AST levels, or with more than 2 times ULN of serum TBIL level, or less than 40% of normal prothrombin time activity (PTA); or with more than 2 times the ULN of serum Cr;

4. Patient with severe active infection;

5. Patient with allergy history about suspected drug in conditioning regimen;

6. Patient with other conditions considered unsuitable for the study.